POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: 04425/0746 .
Flagyl 200mg & 400mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLAGYLTM 400 MG TABLETS
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Flagyl is and what it is used for
2. What you need to know before you take Flagyl
3. How to take Flagyl
4. Possible side effects
5. How to store Flagyl
6. Contents of the pack and other information
1. WHAT FLAGYL IS AND WHAT IT IS USED FOR
The name of this medicine is Flagyl 400mg Tablets (called Flagyl in this leaflet). Flagyl contains a medicine called metronidazole. This belongs to a group of medicines called antibiotics.
It works by killing bacteria and parasites that cause infections in your body.
It can be used to:
If you need any further information on your illness, speak to your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLAGYL
Do not take Flagyl and tell your doctor if:
Do not take Flagyl if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Flagyl.
Warnings and precautions
Talk to your doctor or pharmacist before taking Flagyl if:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking your medicine. Do this even if they have applied in the past.
Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with Flagyl. If you are affected by Cockayne syndrome, your doctor should also monitor your liver function frequently while you are being treated with Flagyl and afterwards.
Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP) have been reported with the use of Flagyl.
The highest risk for occurrence of serious skin reactions is within one week, typically, within 48 hours after start of treatment. If you develop a serious rash or another of these skin symptoms, stop taking Flagyl and contact your doctor or seek medical attention immediately.
Tell your doctor immediately and stop taking Flagyl if you develop: stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.
Other medicines and Flagyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Flagyl can affect the way some other medicines work. Also, some other medicines can affect the way Flagyl works.
In particular tell your doctor if you are taking any of the following medicines:
If you are not sure, talk to your doctor or pharmacist before taking Flagyl.
Flagyl with food, drink and alcohol
Do not drink any alcohol while you are taking Flagyl and for 48 hours after finishing your course. Drinking alcohol while using Flagyl might cause unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heartbeat (palpitations) and headache.
Pregnancy and breast-feeding
Tell your doctor before using Flagyl if:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine
Driving and using machines
While taking Flagyl you may feel sleepy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions) or temporary eyesight problems (such as blurred or double vision). If this happens, do not drive or use any machinery or tools.
Your doctor may wish to carry out some tests if you have been using this medicine for more than 10 days.
3. HOW TO TAKE FLAGYL
Taking your medicine
Always take this medicine exactly as your doctor or pharmacist has told you. It is important to finish a full course of treatment. The length of a course will depend on your needs and the illness being treated.
Check with your doctor or pharmacist if you are not sure.
The usual dose for adults and children is given below:
To treat bacterial infection
To prevent infections from happening after surgery
Other types of infections
For treatment of other infections caused by parasites and some bacteria your doctor will decide how much Flagyl you need to take and how often. This will depend on your illness and how bad it is. The pharmacist’s label on the packaging will tell you how many tablets to take and how often to take them.
People having kidney dialysis
Kidney dialysis removes Flagyl from your blood. If you are having kidney dialysis you must take this medicine after your dialysis treatment.
People with liver problems
Your doctor may tell you to use a lower dose or to take the medicine less often.
If you take more Flagyl than you should
If you take more Flagyl than you should, tell your doctor or go to your nearest hospital casualty department straight away. Take the pack and any tablets left with you. This is so the doctor knows what you have taken.
If you forget to take Flagyl
If you forget to take Flagyl, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Flagyl and see a doctor or go to a hospital straight away if:
Talk to your doctor straight away if you notice the following side effects.
Tell your doctor or pharmacist if you notice any of the following side effects:
Very rare (affects less than 1 in 10 000 people)
Not known (frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or seach for MHRA Yellow card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FLAGYL
Keep your medicine in a safe place and out of the sight and reach of children.
Store below 30º C in the original packaging (protect from light). Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Flagyl Tablets contain
Each tablet contains 400mg of metronidazole as the active substance.
Other ingredients are: calcium hydrogen phosphate (E341), starch maize, povidone K30 (E1201) and magnesium stearate. The coating of the tablets contains: Pharmacoat 615 (E464) and Macrogol 400.
What Flagyl Tablets look like and contents of the pack
Flagyl 400mg Tablets are white to off-white biconvex film coated tablets with ‘Flagyl 400’ printed on one side.
Flagyl 400mg Tablets are available in aluminium/plastic blister packs of 14 tablets and HDPE bottles of 100 tablets.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in March 2021
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